Key Responsibilities
Review analytical data, laboratory records, worksheets, and supporting documents.
Ensure compliance with approved SOPs, specifications, STPs, and GMP requirements.
Review analytical test reports and laboratory documentation for completeness and accuracy.
Support investigation of OOS, OOT, deviations, and laboratory incidents.
Review analytical method validation/verification and related documentation.
Coordinate with QC for timely completion of analytical activities and documentation.
Ensure proper documentation and traceability of laboratory activities.
Participate in internal audits, self-inspections, and regulatory compliance activities.
Support CAPA implementation and effectiveness monitoring.
Review and maintain AQA-related records and reports.
Ensure data integrity and compliance with ALCOA+ principles.
Follow applicable safety, quality, and regulatory requirements.